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Wastewater regulation: EU Parliament prioritises access to medicines

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In its newly agreed position on the wastewater management directive, the European Parliament agreed to shift some of the responsibility for treating water pollution from the polluter to national authorities, to safeguard access to medicines.

With 420 votes in favour, 62 against and 84 abstentions, EU lawmakers adopted on Thursday (5 October) their position on the new rules for the collection, treatment and discharge of urban wastewater with the objective of protecting the environment and human health.

The report strengthens the requirements for monitoring the presence in wastewater of the so-called ‘forever chemicals’ (PFAS), microplastics and pathogens, as well as antimicrobial resistance.

One of the key aspects that the report introduces is the agreement between MEPs on how to address pharmaceutical and cosmetic residues. The report states that, through responsibility systems, producers must contribute to covering the costs of additional treatment of micro-pollutants in urban wastewater. But that of medicines – being vital products, according to EU lawmakers – should be complemented by national funding.

The polluter pays (with help of national funding)

The original text proposed by the European Commission in October last year highlighted that the need to remove the micro-pollutants from urban wastewater will imply additional costs related to monitoring and new advanced equipment to be installed in the current wastewater treatment plants.

To cover these costs, following Article 191 of the Treaty on the Functioning of the European Union (TFEU), producers placing in the EU market products with micro-pollutants take responsibility for this additional treatment required to remove these substances.

The Commission identified pharmaceutical and cosmetic residues as the main sources of micro-pollutants currently found in the wastewater and called for extended producer responsibility (EPR) of these two product groups.

EPR is an environmental policy approach that shifts the responsibility of a product to the producer, from production and design to recycling and final disposal.

The original text considered EPR as the most appropriate solution as “it would limit the financial impact on the taxpayer and water tariff while providing an incentive to develop greener products”.

However, members of the Parliament have adopted amendments to this specific part of the text aiming to ensure the availability, affordability and accessibility of vital products such as medicines and hygiene or sun protection products.

The text adopted by the parliamentarians adds that the producer responsibility “should be complemented by national funding, due to the high societal value of the sectors covered by the extended producer responsibility”.

This national funding shall not be more than 20% and shall not undermine the polluter pays principle of Article 191.

The Parliament’s text also adds that, depending on the country, member states should be given the flexibility to designate which products are classified as vital, together with the European Medicines Agency (EMA) and European Chemicals Agency (ECHA). This list of products will be adapted in the future following scientific and technological developments and new monitored data.

Criticised by the industry

The pharmaceutical industry warned that EPR, as laid out in the first proposal, posed a risk to the manufacturing of their products. Medicines for Europe, representing the generic and biosimilar industry in Europe, stressed that it would be especially dangerous for generic medicines as they have very low margins.

Medicines for Europe, in a press release, welcomed the changes made by the Parliament highlighting the inclusion of the dialogue between stakeholders involved in the EPR implementation “to ensure an efficient process and prevent unintended consequences for medicines availability”.

“The European Parliament ENVI Committees’ efforts to protect patient access to medicines is a positive first step,” said Adrian van den Hoven, Director General at Medicines for Europe.

“We now call on the Council to make the EPR systems fairer for lower-cost generic medicines and to prevent shortages of essential generic medicines across Europe,” he added.

In the new pharmaceutical legislation

Regulating pollution caused by the pharmaceutical industry has been on the Commission’s agenda since the beginning of its mandate. In 2019, it published a communication on the EU’s Strategic Approach to Pharmaceuticals in the Environment, presenting actions to counteract these effects from the design of pharmaceuticals and production to use and disposal.

This communication showed that “even the best, most expensive, current [wastewater] treatments are not 100% effective”.

The proposal for new pharmaceutical legislation also introduced the strengthening of the current environmental risk assessment (ERA) “to ensure a better evaluation and limit the potential adverse impacts of medicines on the environment and public health”.

When assessing marketing authorisation for medicinal products containing or consisting of genetically modified organisms pharmaceutical companies must submit an environmental risk assessment.

This should contain a description of hazards for the environment, animals or public health as well as the probability that the identified threats materialise as well as strategies proposed to address the risks

If the presented ERA is incomplete or insufficient the authorisation for commercialisation will be denied. It will also be extended to all products already in the market and potentially harmful to the environment.

This means that those with marketing authorisations previous to 2006, that did not need to submit an ERA for their application, will have to evaluate their products and assess their environmental risk.

This proposal by the Commission is currently being discussed in the European Parliament, where EU lawmakers have until 14 November to present the amendments in the health committee aiming to reach a common position and move the discussion to the plenary.

[Edited by Giedre Peseckyte/Nathalie Weatherald]

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